Allergic RhinoconjunctivitisPhase 4RANSESNCT06778213
Evaluation of the Efficacy of Allergen-specific Immunotherapy Using Assessment in an Allergen Exposure chamber-a Randomized Placebo-controlled Double-blind Study
A Phase 4 study testing NovoHelisen Depot in people with Allergic Rhinoconjunctivitis, run by Wroclaw Medical University at 1 site in Poland.
Trial summary
The main objective of the study is to measure and correlate clinical parameters suitable for the assessment of allergen immunotherapy (AIT) with an aluminum hydroxide-adsorbed preparation of house dust mite (Dermatophagoides pteronyssinus/ Dermatophagoides farinae) allergens in adults with moderate to severe allergic… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Rhinoconjunctivitis
- What is being tested?
- NovoHelisen Depot
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 sitePoland
- Study dates
- 2 Nov 2024to 1 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible for trial participation, patients must meet all the following inclusion criteria:
- Written informed consent given from patient according to local requirements before any trial-related activities started (a trial-related activity is any procedure that would not have been performed during the routine management of the patient)
- Legally competent male or female outpatient between 18 and ≤ 65 years
- IgE-mediated moderate to severe allergic rhinitis or rhinoconjunctivitis with or without allergic asthma caused by HDM allergens documented by
- Positive Skin prick test (SPT) result to D. pteronyssinus allergens:
- pteronyssinus test solution (wheal diameter) ≥ 3 mm and Positive histamine-control reaction (wheal diameter) ≥ 3 mm and Negative NaCl-control reaction (wheal diameter) < 2 mm Immunoassay result for specific IgE ≥ 0.70 kU/L to D. pteronyssinus
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- Symptoms of rhinitis or rhinoconjunctivitis e.g., during the months October to February or over the entire year for at least 2 years before enrolment.
- Assessment of persistent, moderate-severe rhinitis acc. to ARIA guidelines (Brozek et al.
- 2017, Bousquet et al. 2001) Symptoms for 4 or more consecutive weeks in the previous years and for at least 4 days per week during those weeks More than one of the symptoms evaluated as "troublesome" by the patients and/or impairing their daily activities, leisure or sport, school, or work and/or involving sleep disturbance 6. Symptoms requiring regular intake of anti-symptomatic medication 7. Previous symptomatic anti-allergic medication for at least 2 seasons prior to enrolment 8. At entry to this trial: No diagnosis of bronchial asthma in medical history or confirmed diagnosis of asthma as being "well controlled" according to GINA recommendation (GINA 2022)
Who cannot join
- General criteria:
- Patients are unable to understand and comply with the requirements of the trial, as judged by the investigator
- Currently participating in another clinical trial or participating in any other clinical trial within 30 days prior informed consent for this trial
- Low adherence to trial procedures expected or inability to understand instructions/trial documents
- Involvement in the planning and conduct of the trial
- Any relationship of dependence with the investigator
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- Previous randomization to treatment in the present trial
- Mentally disabled
- Institutionalized due to an official or judicial order For female patients with childbearing potential (i.e., females who are not chemically or surgically sterilized or females who are not post-menopausal)
- Positive urine pregnancy test or pregnant
- Wish to become pregnant during the course of the trial
- Not using highly effective and reliable contraception, as judged by the investigator (reliable and highly effective methods of birth control defined as a failure rate of less than 1% per year [CTFG recommendations 2020]) during the trial. Sexual abstinence is an allowed method of birth control (sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.) Males are not required to use any contraception during the study.
- Wish to breastfeed or breastfeeding
- Immunotherapy criteria:
- History of a confirmed anaphylaxis after an AIT injection
- Current treatment with any kind of AIT
- AIT with HDM allergoids or allergens within the last 5 years
- AIT with unknown allergen within the last 5 years Sensitization criteria
- Clinically relevant symptoms to perennial and seasonal allergens which interfere with the assessment period of October to January. Exceptions are symptoms to allergens of cat and dog, if the patient has no direct contact to these animals.
- Diseases and health status:
- Clinically relevant chronic rhinoconjunctival or respiratory symptoms related to other reasons than allergy
- Chronic persistent rhinitis symptoms for 20 years or longer
- Forced expiratory volume in 1 second (FEV1) < 70 % of predicted normal values according to Quanjer (Quanjer et al. 2012) under adequate asthma treatment according to GINA recommendation (GINA 2022)
- Uncontrolled or partly controlled asthma according to GINA recommendation (GINA 2022)
- Asthma exacerbation within the last 6 months prior to randomization defined as unscheduled doctors visit, hospitalization, or emergency unit visit requiring the use of systemic corticosteroids or change of controller medication
- Severe acute or chronic diseases (e.g., COVID-19, chronic urticaria, mastocytosis, active tuberculosis, diabetes mellitus type I, malignant neoplasia, chronic renal failure), severe inflammatory diseases (liver, kidneys)
- Autoimmune diseases, immune defects including immunosuppression, immune-complexinduced immunopathies (e.g., HIV, post-transplant patients, lupus erythematodes [SLE], vitiligo, Grave's disease, multiple sclerosis)
- Severe psychiatric and psychological disorders including impairment of cooperation (e.g., alcohol or drug abuse)
- Recurrent seizures (e.g., febrile convulsion, untreated epilepsy)
- Irreversible secondary alterations of the reactive organ (e.g., emphysema, bronchiectasis)
- For assessment the normal reference ranges of the central laboratory should be applied. If out of range, laboratory values greater than grade 1 according to the FDA Guidance for Industry (Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials) will lead to exclusion of the patient.
- Medications:
- Use of β-blockers (locally or systemically) and/or angiotensin-converting enzyme (ACE) inhibitors
- Contraindication for use of adrenalin (e.g., acute, or chronic symptomatic coronary heart disease, severe hypertension)
- Completion or ongoing treatment with anti-IgE-antibodies (e.g., omalizumab) or anti IL4/IL13 antibodies (e.g., dupilumab) or other biological medication interfering with the TH2 pathway
- Completed or ongoing long-term treatment with tranquilizer or other psychoactive drugs
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
ALL-MED Medical Research Institute
Wroclaw, DL, 53-201
Magdalena E Zemelka-Wiacek, Dr, +48507019921, magdalena.zemelka-wiacek@umw.edu.pl
Agnieszka Chuda, Msc, +48791340019, agnieszka_chuda@wp.pl
About this study
Official title: A Randomized Placebo-controlled Double-blind Clinical Study for Evaluation of the Efficacy of Allergen-specific Immunotherapy Using Clinical and Biomarker Assessment in an Allergen Exposure Chamber and During Natural Exposure in Patients With House Dust Mite-triggered Allergic Rhinoconjunctivitis RANSES
The main objective of the study is to measure and correlate clinical parameters suitable for the assessment of allergen immunotherapy (AIT) with an aluminum hydroxide-adsorbed preparation of house dust mite (Dermatophagoides pteronyssinus/ Dermatophagoides farinae) allergens in adults with moderate to severe allergic rhinitis/rhinoconjunctivitis with or without controlled allergic bronchial asthma caused by house dust mite (HDM) allergens. The assessment of clinical responses will be evaluated following an allergen challenge in allergen exposure chamber (AEC) before and during the course of AIT. Patients' response to therapy will be evaluated as well as in the AEC and by patient's personal environment (Diary).
Read the detailed description
This clinical trial will be performed as a randomized, double-blind, placebo-controlled phase IV study in adult patients. Thus, 2 parallel groups, one active treated and one placebo group, will be investigated. Patients from 18 to 65 years of age with moderate to severe allergic rhinitis or rhinoconjunctivitis to HDM allergens, with or without controlled allergic bronchial asthma, will be enrolled.
The efficacy will be evaluated using an AEC (TNSS) and additionally in the patient's natural environment (SMS). The screening phase will begin approximately in May and last until September 2024. All patients fulfilling the eligibility criteria at Screening Visit 1 (S1) will perform an AEC visit (AEC-pre) in October, followed by an e-Diary phase in November, December (Diary-pre). For the assessment of the pre-treatment score 4 consecutive weeks will be recorded and at least 2 consecutive weeks with complete daily entries must available. Adequate symptoms are defined as patient randomization criteria in the respective section of the synopsis/protocol. After randomization, patients will be treated for approximately 10 months. Afterwards a second Diary phase (Diary-post) will be performed. For the assessment of the post-treatment score, at least 2 consecutive weeks with complete daily entries must be available. Then, a second, posttreatment challenge (AEC-post) will follow. Last patient last visit is planned for January 2026. For the trial approximately 80 male and female outpatients (18 to 65 years of age) will be screened, and 67 patients will be randomized 1:1 verum/placebo. It is assumed, that this number of patients will yield a total of at least 60 patients with available post-treatment assessments, assuming a dropout rate of 10%. Additionally, data from 11 healthy subjects from a previous study with an identical setting will be included in the correlation analysis. There will be no replacement strategy employed for patients dropping out prematurely.
- Conditions
- Allergic Rhinoconjunctivitis
- Being tested
- NovoHelisen Depot
- Keywords
- allergen-specific immunotherapy, biomarker assessment, allergen exposure chamber, house dust mite, allergic rhinoconjunctivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NovoHelisen DepotBiological
allergen immunotherapy treatment for 12 months with house dust mite allergen preparation
| Study group | Role | What they receive |
|---|---|---|
| verum | Active comparator | Immunotherapy - NovoHelisen Depot according to desensitisation protocol 5 times weekly increasing injections 250-5000 TU, 10 times monthly maintenance injections 5000 TU Receives: Biological: NovoHelisen Depot |
| placebo | Placebo comparator | 5 times weekly increasing placebo injections, 10 times monthly placebo injections Receives: Biological: NovoHelisen Depot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total nasal symptom score
The primary efficacy analysis is the analysis of correlation between TNSS recorded in the AEC and the average CSMS over 2 weeks as recorded in the eDiary.
Measured: 12 months
Secondary outcomes (2)
Change of the TNSS
Change of the TNSS at 120 minutes recorded in the AEC from pre-treatment to post treatment, calculated as post treatment TNSS - pre-treatment TNSS, and Change in average CSMS from pre-treatment to post-treatment calculated as post treatment CSMS - pre-treatment CSMS
Measured: 12 months
Change in average CSMS
Change in average CSMS from pre-treatment to post-treatment calculated as post treatment CSMS - pre-treatment CSMS
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start2 Nov 2024
- Primary completion2 Apr 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Allergic RhinoconjunctivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized placebo-controlled double-blind study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- ALL-MED Medical Research Institute, Wroclaw, Poland, Allergopharma GmbH & Co. KG
- Responsible party
- Principal investigator, Marek Jutel, Wroclaw Medical University
- Investigators
- Agnieszka M Chuda, MSc, Study director, ALL-MED Specjalistyczna Opieka Medyczna. Medyczny Instytut Badawczy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06778213
- Sponsor's protocol ID
- ALL-MED
- Acronym
- RANSES
- Status last verified
- Jan 2025
- First submitted
- 10 Jan 2025
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jutel M, Zemelka-Wiacek M, Okamoto Y, Pfaar O. Algorithms in Allergy: Assessment of Rhinitis Using Allergen Exposure Chambers. Allergy. 2025 Mar;80(3):904-907. doi: 10.1111/all.16444. Epub 2024 Dec 17. No abstract available.
PubMed 39688144Zemelka-Wiacek M, Kosowska A, Jutel M. Symptom Assessment of Patients with Allergic Rhinitis Using an Allergen Exposure Chamber. J Vis Exp. 2023 Mar 3;(193). doi: 10.3791/64801.
PubMed 36939263Zemelka-Wiacek M, Kosowska A, Winiarska E, Sobanska E, Jutel M. Validated allergen exposure chamber is plausible tool for the assessment of house dust mite-triggered allergic rhinitis. Allergy. 2023 Jan;78(1):168-177. doi: 10.1111/all.15485. Epub 2022 Sep 1.
PubMed 35980665Kosowska A, Zemelka-Wiacek M, Smolinska S, Wyrodek E, Adamczak B, Jutel M. Clinical validation of grass pollen exposure chamber in patients with allergic rhinitis triggered by timothy grass. Clin Exp Allergy. 2024 Jul;54(7):489-499. doi: 10.1111/cea.14482. Epub 2024 Apr 14.
PubMed 38616622
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Placebo-controlled Double-blind Clinical Study for Evaluation of the Efficacy of Allergen-specific Immunotherapy Using Clinical and Biomarker Assessment in an Allergen Exposure Chamber and During Natural Exposure in Patients With House Dust Mite-triggered Allergic Rhinoconjunctivitis RANSES
- ClinicalTrials.gov ID
- NCT06778213
- Acronym / sponsor ID
- RANSES / ALL-MED
- Conditions
- Allergic Rhinoconjunctivitis
- Keywords
- allergen-specific immunotherapy, biomarker assessment, allergen exposure chamber, house dust mite, allergic rhinoconjunctivitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Collaborators
- ALL-MED Medical Research Institute, Wroclaw, Poland, Allergopharma GmbH & Co. KG
- Study start
- 2 Nov 2024 (actual)
- Primary completion
- 2 Apr 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 16 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of the study is to measure and correlate clinical parameters suitable for the assessment of allergen immunotherapy (AIT) with an aluminum hydroxide-adsorbed preparation of house dust mite (Dermatophagoides pteronyssinus/ Dermatophagoides farinae) allergens in adults with moderate to severe allergic rhinitis/rhinoconjunctivitis with or without controlled allergic bronchial asthma caused by house dust mite (HDM) allergens. The assessment of clinical responses will be evaluated following an allergen challenge in allergen exposure chamber (AEC) before and during the course of AIT. Patients' response to therapy will be evaluated as well as in the AEC and by patient's personal environment (Diary).
Detailed description
This clinical trial will be performed as a randomized, double-blind, placebo-controlled phase IV study in adult patients. Thus, 2 parallel groups, one active treated and one placebo group, will be investigated. Patients from 18 to 65 years of age with moderate to severe allergic rhinitis or rhinoconjunctivitis to HDM allergens, with or without controlled allergic bronchial asthma, will be enrolled.
The efficacy will be evaluated using an AEC (TNSS) and additionally in the patient's natural environment (SMS). The screening phase will begin approximately in May and last until September 2024. All patients fulfilling the eligibility criteria at Screening Visit 1 (S1) will perform an AEC visit (AEC-pre) in October, followed by an e-Diary phase in November, December (Diary-pre). For the assessment of the pre-treatment score 4 consecutive weeks will be recorded and at least 2 consecutive weeks with complete daily entries must available. Adequate symptoms are defined as patient randomization criteria in the respective section of the synopsis/protocol. After randomization, patients will be treated for approximately 10 months. Afterwards a second Diary phase (Diary-post) will be performed. For the assessment of the post-treatment score, at least 2 consecutive weeks with complete daily entries must be available. Then, a second, posttreatment challenge (AEC-post) will follow. Last patient last visit is planned for January 2026. For the trial approximately 80 male and female outpatients (18 to 65 years of age) will be screened, and 67 patients will be randomized 1:1 verum/placebo. It is assumed, that this number of patients will yield a total of at least 60 patients with available post-treatment assessments, assuming a dropout rate of 10%. Additionally, data from 11 healthy subjects from a previous study with an identical setting will be included in the correlation analysis. There will be no replacement strategy employed for patients dropping out prematurely.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A randomized placebo-controlled double-blind study
| Arm | Type | Receives |
|---|---|---|
| verum | Active comparator | Biological: NovoHelisen DepotImmunotherapy - NovoHelisen Depot according to desensitisation protocol 5 times weekly increasing injections 250-5000 TU, 10 times monthly maintenance injections 5000 TU |
| placebo | Placebo comparator | Biological: NovoHelisen Depot5 times weekly increasing placebo injections, 10 times monthly placebo injections |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- To be eligible for trial participation, patients must meet all the following inclusion criteria:
- Written informed consent given from patient according to local requirements before any trial-related activities started (a trial-related activity is any procedure that would not have been performed during the routine management of the patient)
- Legally competent male or female outpatient between 18 and ≤ 65 years
- IgE-mediated moderate to severe allergic rhinitis or rhinoconjunctivitis with or without allergic asthma caused by HDM allergens documented by
- Symptoms of rhinitis or rhinoconjunctivitis e.g., during the months October to February or over the entire year for at least 2 years before enrolment.
Key exclusion criteria (36 listed)
- Patients are unable to understand and comply with the requirements of the trial, as judged by the investigator
- Currently participating in another clinical trial or participating in any other clinical trial within 30 days prior informed consent for this trial
- Low adherence to trial procedures expected or inability to understand instructions/trial documents
- Involvement in the planning and conduct of the trial
- Any relationship of dependence with the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NovoHelisen Depotallergen immunotherapy treatment for 12 months with house dust mite allergen preparation | Biological | placebo, verum |
Primary outcome
Total nasal symptom score
Time frame: 12 months
The primary efficacy analysis is the analysis of correlation between TNSS recorded in the AEC and the average CSMS over 2 weeks as recorded in the eDiary.
2 secondary outcomes
Change of the TNSS
Time frame: 12 months
Change in average CSMS
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Background: PubMed 39688144Jutel M, Zemelka-Wiacek M, Okamoto Y, Pfaar O. Algorithms in Allergy: Assessment of Rhinitis Using Allergen Exposure Chambers. Allergy. 2025 Mar;80(3):904-907. doi: 10.1111/all.16444. Epub 2024 Dec 17. No abstract available.
- Background: PubMed 36939263Zemelka-Wiacek M, Kosowska A, Jutel M. Symptom Assessment of Patients with Allergic Rhinitis Using an Allergen Exposure Chamber. J Vis Exp. 2023 Mar 3;(193). doi: 10.3791/64801.
- Results publication: PubMed 35980665Zemelka-Wiacek M, Kosowska A, Winiarska E, Sobanska E, Jutel M. Validated allergen exposure chamber is plausible tool for the assessment of house dust mite-triggered allergic rhinitis. Allergy. 2023 Jan;78(1):168-177. doi: 10.1111/all.15485. Epub 2022 Sep 1.
- Results publication: PubMed 38616622Kosowska A, Zemelka-Wiacek M, Smolinska S, Wyrodek E, Adamczak B, Jutel M. Clinical validation of grass pollen exposure chamber in patients with allergic rhinitis triggered by timothy grass. Clin Exp Allergy. 2024 Jul;54(7):489-499. doi: 10.1111/cea.14482. Epub 2024 Apr 14.
- ALLEC Allergen Exposure ChamberLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Agnieszka M Chuda, MSc study director
ALL-MED Specjalistyczna Opieka Medyczna. Medyczny Instytut Badawczy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing NovoHelisen Depot in people with Allergic Rhinoconjunctivitis, run by Wroclaw Medical University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marek M Jutel, prof. (+48731021221, marek.jutel@all-med.wroclaw.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total nasal symptom score (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06778213, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.